Kornimate/medical-research-clean huggingface dataset:
noninvasive assessment of metabolic associated fatty liver disease (mafld) in chinese population

Conditions: Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

Summary: attenuation imaging (ati) technology independently developed by canon medical is a non-invasive examination technology for quantitative detection and analysis of liver steatosis. the technique is simple, rapid and quantitative diagnosis, and is suitable for screening and popularization of early liver steatosis in mafld. as noninvasive and effective detection measures of liver inflammation and liver fibrosis, swd and swe are more and more widely used in the quantitative diagnosis of liver inflammation and fibrosis. therefore, ati combined with swd / swe detection can quantitatively diagnose different pathological stages (steatosis, necrotizing inflammation and liver fibrosis) in the development of mafld, so as to provide an important basis for treatment.


Eligibility criteria:
inclusion criteria: 1. being a chinese citizen aged 18 to 85 years; 2. meeting the diagnostic criteria for mafld; 3. willing and able to provide informed consent; 4. having a platelet count of at least 50 × 109/l and prothrombin activity of ≥50%. exclusion criteria: 1. the pregnant. 2. patients who have received or are undergoing systemic chemotherapy. 3. patients with hepatitis c, alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 40g / d in male and ≥ 20g / d in female), drug-induced liver disease or autoimmune hepatitis. 4. those who re fuse to sign informed consent; 5. there was a significant risk of bleeding (platelet \< 50x109 / l, prothrombin activity \< 50%).
dry needling with and without kinesio taping® in the non-specific chronic low back pain

Conditions: Non-Spesific Chronic Low Back Pain

Summary: we wiil evaluate the efficiency of adding kinesio taping (kt) therapy to dry needling (dn) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nclbp).

a total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in dn therapy. kt application will be performed after every dn session in the study group. pain will evaluate with visual analog scale, functionality was evaluated with oswestry disability index and the status of depression will be evaluated with beck depression index before the treatment and at the first month.

Eligibility criteria:
inclusion criteria: * having no abnormal results in routine blood tests * having no known acute or chronic inflammatory disease * an education level required for understanding the applied treatment, interventions exclusion criteria: * malignancies * active infection * history of common inflammatory rheumatic disease * trauma in spinal area, skin lesion, presence of infection or open wounds * radiculopathy * peripheral circulation disorder * use of warfarin due to coagulopathy * arthropathy * congenital or acquired spinal pathology * pregnancy

Keywords: dry needling kinesiotape low-back pain
fostering shared decision-making about prostate cancer screening among clinicians and african american men

Conditions: Prostate Cancer

Summary: this behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (psa)-based screening for prostate cancer among african american males. half of participants will receive a multimedia educational intervention, while the other half will receive usual care.

the 2018 u.s. preventive services task force (uspstf) final recommendation states that male patients and their providers engage in a shared-decision making process about the benefits and harms of psa-based screening. as characterized by the uspstf, these conversations are particularly important for african american men given increased ambiguity due to the lack of psa-based research specific to this population and increased risk of prostate cancer mortality attributed to late stage at diagnosis and more aggressive prostate cancer phenotypes seen in african american men. the goal of this randomized behavioral clinical trial is to advance the translation path of implementing the decision-making process in clinical encounters by evaluating the efficacy of an educational intervention for african american males to increase shared decision making about psa-screening versus usual care. the intervention will use multimedia educational training materials to increase understanding of prostate cancer, psa-based screening, and shared decision making among patients and their primary care providers (pcps).

Eligibility criteria:
patient inclusion criteria: * receiving care at the clinical sites * identify as african american male * ages 40-69 years old patient exclusion criteria: * personal history of prostate cancer at the time of consent * cognitive impairment that would interfere with participation in the study * unable to complete any aspect of the intervention within the specified time limit

Keywords: prostate cancer primary care psa-screening african american males
a trial of hrs-2261 in healthy subjects after single and multiple oral administration

Conditions: Chronic Cough

Summary: this is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of hrs-2261 using a double blind, placebo controlled, randomized study design. the influence of food on the pharmacokinetics of hrs-2261 and the effects of hrs-2261 on cyp3a4 metabolic enzymes will also be investigated.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent. 2. age 18 to 55 years (inclusive). 3. weight of male subjects ≥50 kg, female ≥45kg, body mass index (bmi) 19-26 kg/m2 (inclusive). 4. medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal b-ultrasound and chest radiography) normal or abnormal with no clinical significance. exclusion criteria: 1. any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results. 2. subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; subjects who plan to undergo surgery during the trial period and within two weeks after the trial. 3. treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration. 4. subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator. 5. subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening. 6. subjects who had a history of smoking in the previous 3 months (average daily smoking \> 5 cigarettes), or who could not stop using any tobacco products during the test period. 7. subjects who consumed more than 15g of alcohol per day on average (15g of alcohol is equivalent to 450 ml beer, 150 ml wine or about 50ml low-alcohol white wine) or tested positive for alcohol during the 3 months prior to screening, or who could not abstain from alcohol during the test period. 8. subjects with a history of drug abuse, drug dependence or positive drug screening. 9. determined by the investigator to be unfit to participate in this clinical trial.
randomized, double-blind evaluation of maple leaf extract (maplifa) for photoaging

Conditions: Photoaging; Hyperpigmentation; Rhytides

Summary: recent research has reported that the maple leaf extract exhibits anti-aging effects by inhibiting elastase activity, thereby preventing the breakdown of elastin and interfering with the formation of wrinkles. red maple leaf extract contains phenolic compounds known as glucitol-core-containing gallotannins (gcgs) which help reduce the appearance of wrinkles and may decrease skin inflammation, dark spots and pigmentation. the objective of this study is to examine the effects of topical maplifa on the cosmetic appearance of facial lines, redness and skin tone.


Eligibility criteria:
inclusion criteria: * females aged 30-70 * individuals with fitzpatrick skin type i-iv exclusion criteria: * individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator * individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator * individuals who have participated in any other clinical studies using the same test sites (face) and hand in the past 14 days * individuals who are pregnant, breast feeding or planning a pregnancy within one month. (there is no concern for risk to fetus but pregnancy can alter skin pigmentation). * female volunteers who have started a new hormonal birth control agent or had a change in their hormonal birth control agent within the past 60 days * individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. this includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure * individuals who are currently using or during the past 30 days have used a retinoid such as retin a, or other rx/otc retinyl a or currently using or during the past 14 days have used hydroquinone (skin lightening) * individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed * individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.

Keywords: maple leaf extract skincare photoaging hyperpigmentation
quadriblock versus "ipack + femoral triangle block + obturator nerve block" in total knee arthroplasty

Conditions: Primary Total Knee Arthroplasty

Summary: total knee arthroplasty (tka) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery. postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (la). for optimal pain management, several peripheral nerve blocks should be associated. thus, a recent study shows that the combination of ipack, femoral triangle and obturator nerve blocks (ito blocks) provides an effective pain control after tka. the hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after tka. the main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after tka compared to ito blocks.

in the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to sfar (french society of anesthesia \& intensive care medecine) recommendations and injection of 10 mg of iv dexamethasone. the patients will be then randomized in 2 groups: * ito group (usual technique): ipack combined to femoral triangle and obturator nerve blocks * quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks. an experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml. in the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). anesthesia will be maintained with propofol. postoperative analgesia protocol : * multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg). * in post-anesthesia care unit (pacu): oxynorm titration if vrs (pain score) \>3 according to the centre's usual care. * in ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if vrs (pain score) \>3.

Eligibility criteria:
inclusion criteria: * 18 years and older, * primary total knee arthroplasty * consent for participation, * affiliation to a social security system exclusion criteria: * preoperative morphine use * chronic pain syndrome * contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine) * valgus \> 9° * pregnant or breastfeeding women * patients under protection of the adults (guardianship, curators or safeguard of justice)

Keywords: knee arthroplasty, regional anesthesia, ropivacaine, postoperative analgesia, pain management, opioids
fatty acid metabolism in obstructive sleep apnea (famosa)

Conditions: Obstructive Sleep Apnea; Fatty Acid Metabolism; Continuous Positive Airway Pressure

Summary: obstructive sleep apnea syndrome (osa) is a disease affecting 5-15% of population and 50-80% of type 2 diabetes mellitus (t2dm) and obese subjects. osa causally contributes to the development of glucose intolerance and t2dm. the project is targeting the gap in providing effective treatment of metabolic impairments associated with osa, particularly t2dm. in contrast to proved benefits of osa treatment with cpap (continuous positive airway pressure) on cardiovascular morbidity/mortality, studies on the impact of cpap on diabetes control are disappointing. in fact, osa-induced metabolic impairments might not be reversible with cpap treatment, as investigators suggested recently. clearly, the search for additional treatments, probably pharmacological, is warranted. investigators hypothesize that elevated levels of free fatty acids (ffa), as detected in osa patients, are linking osa with the t2dm development. the aim of the study is to target adipose tissue and muscle dysfunction leading to elevated ffa and develop thus novel pharmacological treatments based on lipolysis inhibition and stimulation of ffa oxidation.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age 18 - 85 years * bmi 22-40 kg/m2 * moderate or severe osa diagnosed by home sleep study exclusion criteria: * treatment with insulin * other acute or chronic endocrine or inflammatory disease
sapt versus dapt in incomplete revascularization after cabg

Conditions: Coronary Artery Disease

Summary: the study aims to compare the efficacy of dual antiplatelet therapy (dapt) over single antiplatelet therapy (sapt) in patients with incomplete revascularization after coronary artery bypass graft surgery (cabg). before hospital discharge, patients will be 1:1 randomized to sapt (acetylsalicylic acid 100 mg/die) or dapt (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). dapt will be continued for 12 months, and ticagrelor will be withdrawn thereafter. primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.


Eligibility criteria:
inclusion criteria: * patients undergoing cabg, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...) * incomplete myocardial revascularization, defined by anatomic or functional criteria * obtained informed consent exclusion criteria: * acute coronary syndrome \< 12 months from surgery * dual antiplatelet therapy at hospital admission * planned procedure to complete myocardial revascularization (e.g. hybrid approach) * intolerance / unable to take acetylsalicylic acid or ticagrelor * preoperative atrial fibrillation * impaired compliance * planned pregnancy * history of gastrointestinal bleeding * chronic kidney disease (egfr \< 30 ml/min/1.73 m2) * chronic liver disease * severe heart failure at hospital admission * active malignancy * alcohol abuse * any clinical condition not compatible with the treatment exit criteria: * postoperative atrial fibrillation requiring anticoagulation * postoperative hemorrhagic events (stroke, gi bleeding) * occurrence of contraindications to acetylsalicylic acid or ticagrelor * surgical treatment requiring dapt withdrawn * patient decision

Keywords: coronary artery bypass grafting incomplete revascularization coronary artery disease dual antiplatelet therapy
composition of the exhaust gas of pneumoperitoneum during laparoscopic surgery

Conditions: Pneumoperitoneum

Summary: this research aims to study the composition of the peritoneal exhaust gas during laparoscopic surgery to detect and possibly quantify the presence of air and / or n2o. this purely descriptive work is part of other experimental work that the investigators have already published.


Eligibility criteria:
inclusion criteria: * adult patient * patient who will benefit from a laparoscopic surgery at strasbourg university hospitals * patient who has consented to the use of her medical data for research purposes. exclusion criteria: - refusal of the patient to participate in the study

Keywords: pneumoperitoneum exhaust gas chromatographic study nitrous oxide nitrogen dioxide
spica casting in pediatric femur fractures: study of single leg versus double leg spica casts

Conditions: Femur Fracture

Summary: prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.

introduction * double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old. * investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment. methods * prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures * patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained * radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation * after casts removal, the activity scale for kids (performance version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.

Eligibility criteria:
inclusion criteria: * diaphyseal femur fracture * age between 2 and 6 years old exclusion criteria: * underlying bone disorder * neuromuscular disease

Keywords: pediatric femur femoral fracture spica cast diaphyseal single double patient age 2 to 6 years old
the impact of low pressure pneumo in rarp

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (rarp).

laparoscopic and robotic surgery has revolutionized post-operative outcomes across surgical specialties. however, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. the effects of increased intra-abdominal pressure on cardiopulmonary function has been well documented. increased pressure on the large vessels may lead to decreased cardiac output and thereby decreased blood flow to various organ systems and cause irreversible damage. some studies have advocated lower pressures to further optimize cardiopulmonary parameters. mcdougall, et. al, for instance, demonstrated a significant reduction in oliguria when pressures of 10mm hg were used. the purpose of this study is to evaluate the effect of using lower pressure pneumoperitoneum in the abdominal cavity during rarp. the investigators hypothesize that low pressure pneumoperitoneum has a multitude of clinical benefits due to improved physiologic parameters including a reduction in the occurrence of post-operative ileus, reduced need for narcotics post operatively, and a decrease in cardiopulmonary complications. the study is a prospective randomized blinded cohort study. patients who meet eligibility criteria will be randomly assigned to undergo rarp at a pneumoperitoneum pressure of 12mm hg or 8mm hg. this will be done by computer generated randomization protocol. surgeon and patients will be blinded to the pneumoperitoneum pressure used. a cover will be placed over the airseal™ system so that the surgeon(s) are not able to visualize the pneumoperitoneum used during the procedure. the remainder of the procedure will be carried out based on current standard of care. all patients will be admitted post operatively and the same standardized order-set in epic ehr will be used for all patients in order to control for other factors, such as opioid use, to control for confounders.

Eligibility criteria:
inclusion criteria: * male 40 years of age or older * diagnosis of prostate cancer * have been evaluated to be fit for proposed surgery * patients able to consent exclusion criteria: * patients unable to consent (cognitively impaired) * non-english speaking

Keywords: radical prostatectomy robotic assisted radical prostatectomy
supplementing brief psychotherapy with a mobile app

Conditions: Suicide and Self-harm; Emotion Regulation

Summary: suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. even among those who do attend therapy, however, the skills learned in treatment may be difficult to use during the highly distressing time leading up to and during a suicide crisis. most traditional treatments are not designed to be effective during a suicide crisis. in order to reduce the risk of suicidal thoughts and behaviors in general and specifically during the post-discharge period, interventions are needed that: (1) are easily adhered to and (2) are accessible and effective during a suicide crisis. as such, the purpose of this research study is to test an innovative, new intervention in order to develop an effective and accessible intervention for those at high risk for suicide


Eligibility criteria:
inclusion criteria: * adult status (18+ years) * admission to eligible units in our partner hospital with a reason for admission having to do with suicide risk * the ability to speak and write english fluently, * ownership of and consistent access to an internet-capable smartphone (e.g., an iphone or android phone) exclusion criteria - the presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write english fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.

Keywords: suicidal ideation suicide attempts